Device and method for analyzing body fluids

Abstract

A device for analyzing body fluids comprising a lancing element that can puncture a body part along a lancing axis. The lancing element has a collection volume for collecting body fluid obtained by a puncture and a receiving element that can be loaded with body fluid from the collection volume and that can detect a component of the body fluid. The lancing element and the receiving element are arranged in the lancing axis so that they can be moved relative to one another such that the receiving element dips into the collection volume in the lancing direction during a transfer phase following the puncture.

1 . A device for analyzing body fluids which is especially useful for blood sugar tests, comprising a lancing element that moves during a lancing phase along a lancing axis to puncture a body part, the lancing element having a collection volume for collecting body fluid obtained by a puncture and a receiving element that can be loaded with body fluid from the collection volume, the receiving element detecting a component of the body fluid during use of the device, wherein the lancing element and the receiving element are moveable relative to one another along the lancing axis and the receiving element is arranged in an initial position away from the collection volume such that the receiving element does not contact the body part during the puncture, and wherein the receiving element enters the collection volume during a transfer phase following the lancing phase. 
     
     
         2 . The device of  claim 1 , wherein the lancing element has a distal lancing member, the distance between the lancing member and the receiving element being smaller in the transfer phase than in the lancing phase. 
     
     
         3 . The device of  claim 1 , further comprising a lancing drive coupled to the lancing element, the receiving element being movable into the collection volume by a retracting movement of the lancing drive. 
     
     
         4 . The device of  claim 1 , further comprising a feed drive which moves the receiving element into the collection volume. 
     
     
         5 . The device of  claim 1 , wherein the lancing element or the receiving element have a docking structure for a detachable drive. 
     
     
         6 . The device of  claim 1 , further comprising a linear guide in which the lancing element is mounted. 
     
     
         7 . The device of  claim 1 , wherein the lancing element comprises a recess leading to the collection volume, the receiving element engaging the recess. 
     
     
         8 . The device of  claim 1 , wherein the lancing element and the receiving element together comprise a disposable part. 
     
     
         9 . The device of  claim 8 , further comprising a magazine having a plurality of lancing elements and associated receiving elements. 
     
     
         10 . The device of  claim 9 , wherein the receiving element comprises a measuring member for an optical or electrochemical measurement in the collected body fluid. 
     
     
         11 . The device of  claim 10 , wherein the measuring member is coated with a test reagent that reacts with the component of the body fluid while under liquid contact. 
     
     
         12 . The device of  claim 10 , wherein the receiving element is connectable to a measuring unit via a light guide routed in the lancing element. 
     
     
         13 . The device of  claim 1 , wherein the collection volume comprises a slot or channel of the lancing element. 
     
     
         14 . The device of  claim 1 , wherein the collection volume has a capacity of less than 10 nl body fluid. 
     
     
         15 . The device of  claim 1 , wherein, during use of the device, an aliquot of the body fluid is transferred from the collection volume onto a distal front side of the receiving element, the aliquot being less than 5 nl. 
     
     
         16 . The device of  claim 1 , further comprising a lancing drive that can be triggered by a user. 
     
     
         17 . The device of  claim 1 , further comprising a measuring unit that interacts with the receiving element to detect the component of the body fluid. 
     
     
         18 . A method for analyzing body fluids in a device of the type having a lancing element comprising a collection volume and a receiving element, the method comprising:
 moving the lancing element along a lancing axis and into a body part during a lancing phase;   drawing body fluid into the collection volume;   moving the receiving element and the collection volume relative to one another along the lancing axis during a transfer phase to bring the receiving element in contact with body fluid in the collection volume;   loading the receiving element with a portion of the body fluid; and   testing the body fluid loaded on the receiving element for the presence or concentration of a component of interest.   
     
     
         19 . The method of  claim 18 , wherein the distance between the receiving element and a distal lancing member of the lancing element is reduced in the transfer phase. 
     
     
         20 . The method of  claim 18 , wherein the receiving element is moved together with a lancing member of the lancing element during the lancing phase. 
     
     
         21 . The method of  claim 18 , further comprising driving a lancing member of the lancing element in a reciprocating lancing movement while holding the receiving element stationary. 
     
     
         22 . The method of  claim 18 , wherein the lancing element is located outside the body part containing the body fluid in the transfer phase. 
     
     
         23 . The method of  claim 18 , wherein the testing comprises an optical or electrochemical measurement. 
     
     
         24 . A method of sterilizing a disposable lancing element of the type comprising a lancing member defining a collection volume therein and a receiving element coated with a reagent that produces a detectible response when contacted with a biological fluid having a component of interest, the receiving element and the collection volume being movable relative to one another along a lancing axis of the lancing member, the method comprising maintaining the receiving element at a distance from the lancing member of the lancing element and irradiating the lancing member. 
     
     
         25 . The method of  claim 24 , further comprising selecting the distance to be sufficiently large such that the test reagent is not damaged by the irradiation. 
     
     
         26 . The method of  claim 24 , wherein the radiation comprises an electron beam, the method further comprising focusing the electron beam on the lancing member such that the test reagent is not damaged by the radiation. 
     
     
         27 . An apparatus for analyzing body fluids, comprising:
 a housing;   a lancing element movable relative to the housing along a lancing axis to puncture a body part, the lancing element defining a collection volume in which body fluid is collected; and   a receiving element which produces a detectible response when contacted with body fluid having a component of interest, the receiving element and collection volume being movable relative to one another along the lancing axis between a first position in which the receiving element is remote from the collection volume and a second position in which the receiving element extends into the collection volume.   
     
     
         28 . The apparatus of  claim 27 , further comprising a lancing phase during which the lancing element is moved along the lancing axis in a puncturing direction to puncture a body part followed by a transfer phase during which the collection volume and receiving element are moved from the first position to the second position. 
     
     
         29 . The apparatus of  claim 28 , further comprising a lancing drive coupled to the lancing element, wherein the receiving element and collection volume are moved into the second position by a retracting movement of the lancing drive during the transfer phase. 
     
     
         30 . The apparatus of  claim 28 , wherein the receiving element remains stationary relative to the housing during the puncture phase. 
     
     
         31 . The apparatus of  claim 28 , wherein the receiving element moves with the lancing element during the puncture phase. 
     
     
         32 . The apparatus of  claim 27 , further comprising a feed drive which moves the receiving element into the collection volume. 
     
     
         33 . The apparatus of  claim 27 , further comprising a linear guide in which the lancing element is mounted. 
     
     
         34 . The apparatus of  claim 27 , wherein the lancing element comprises a recess in which the receiving element is located, the receiving element being movable relative to the recess. 
     
     
         35 . The apparatus of  claim 27 , wherein the receiving element comprises a measuring member for an optical or electrochemical measurement of collected body fluid. 
     
     
         36 . The apparatus of  claim 27 , wherein the measuring member is coated with a test reagent that reacts with the component of the body fluid. 
     
     
         37 . The apparatus of  claim 27 , further comprising a light guide connected to the receiving element. 
     
     
         38 . The apparatus of  claim 37 , wherein the light guide is routed in the lancing element. 
     
     
         39 . The apparatus of  claim 27 , wherein the collection volume comprises a slot or channel of the lancing element.